GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231212Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132622320), received between Aug 29, 2018 and Dec 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE, AROUND (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231212/(B)(6). THE GORE SALES FIELD ASSOCIATED (FSA) REPORTED THE FOLLOWING: ¿IMPLANTED AND EXTRACTED ITEM DID NOT DEPLOY¿. THE FSA MENTIONED THAT HE WAS ASKED TO PICK UP THE DEFECTIVE DEVICE WITHOUT ANY INFORMATION ON THE ISSUE. WHILE THE DEVICE HAD BLOOD ON IT, IT LOOKED FULLY INTACT AND UNDEPLOYED. THE EXPLANATION THE GORE ASSOCIATE WAS ABLE TO GATHER, WAS THAT IT WAS PUT INTO THE PATIENT, DID NOT DEPLOY, WAS SAFELY REMOVED AND REPLACED WITH A LIKE DEVICE AND THE CASE WAS COMPLETED. REPORTEDLY, THE PROCEDURE WAS COMPLETED BY AN EXPERIENCED SURGEON WITHOUT CASE SUPPORT FROM GORE. THERE WAS NO ADVERSE EVENT. THE DEVICE DID NOT HAVE ANY DOCUMENTATION ATTACHED. NO MORE INFORMATION IS AVAILABLE. THE DEVICE WILL BE PROVIDED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 20931347 ↗
• InjuryMar 15, 2022Mechanical Problem; Mechanical Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS COULD NOT BE RECONSTRAINED. THE PHYSICIAN DEPLOYED THE DEVICE, INTENTIONALLY HIGH, PLANNING TO RECONSTRAIN IF NEEDED. THE DEVICE (THE SCALLOP AT DISTAL END OF GRAFT) PARTIALLY COVERED THE LEFT RENAL ARTERY. AN ANGIOGRAPH WAS PERFORMED AND SHOWED FLOW INTO THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE FIELD SALES ASSOCIATED STATED ¿THE CLEAR DIAL BECAME DISLODGED DURING SHIPPING¿.

  Patient problems: Aneurysm

  MAUDE report 13772519 ↗
• InjuryAug 29, 2018Complete Blockage; Complete Blockage

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A BARE METAL STENT IN THE RIGHT EXTERNAL ILIAC ARTERY TO TREAT VESSEL OCCLUSION DISTAL TO THE PREVIOUSLY IMPLANTED STENT GRAFT. ON AN UNKNOWN DATE, ADDITIONAL NON-GORE MANUFACTURED STENTS WERE PLACED ON THE RIGHT SIDE, EXTENDING FROM THE RIGHT COMMON FEMORAL ARTERY DOWN TO THE SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2018, THE PATIENT PRESENTED TO THE FACILITY WITH RIGHT LEG ISCHEMIA. FOLLOW-UP IMAGING REPORTEDLY SHOWED COMPLETE STENT OCCLUSION FROM THE FLOW DIVIDER THROUGH THE RIGHT SFA. ON THE SAME DAY, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY A CUT-DOWN WAS PERFORMED DISTAL TO THE STENT GRAFT SYSTEM, AND THE LENGTH OF THE GRAFT WAS DE-CLOTTED USING BALLOON ANGIOPLASTY (FOGARTY CATHETERS). COLLATERALIZATION AND FLOW TO THE RIGHT FOOT REPORTEDLY WAS ALSO ACHIEVED DURING THE PROCEDURE. DEVICE PATENCY WAS RESTORED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 7827461 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)